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Malfunctioning Defibrillators: What is the Safe Medical Device Act?

Nearly 300,000 Americans collapse each year when their hearts stop pumping in a normal rhythm. Without immediate medical attention, they are at risk of death from cardiac arrest. Automated external defibrillators (AED’s) are portable devices used to treat heart arrhythmia by shocking the heart back into a normal rhythm. An AED offers the best chance of survival after a heart attack. However, malfunctioning AEDs can cost lives rather than saving them.

Between 2005 and 2010, the Food and Drug Administration (FDA) received more than 28,000 reports of malfunctioning defibrillators and 68 AED recalls were issued.

How does the FDA receive these reports and how are recalls issued?

The Safe Medical Devices Act is a federal law that was enacted in 1990. The SMDA was an update to the Federal Food, Drug and Cosmetic Act, which had not been modified since 1976. Before 1990, there was no way for the government to track defective medical devices that could potentially cause injury.

The SMDA requires health-care professionals to report deaths or injuries that may be related to a particular medical device to the Food and Drug Administration (FDA). Adverse events must be reported even if the doctor is uncertain that the product caused the event. Reports are made through a medical reporting program called MEDWATCH. The FDA must follow up on all reports of medical device malfunctions and issue a recall if there is a risk of injury from the device.

Consumers may also make a report on the MedWatch website or by calling 1-800-FDA-1088.

If you have lost a loved one because of a malfunctioning AED, an AED lawsuit may bring accountability for your loss. West Palm Beach heart attack injury attorney Craig Goldenfarb has led the efforts to improve AED safety and save lives.

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